The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

The deal hands AbbVie a drug that’s shown early promise in multiple myeloma and may be useful treating other cancers and ...

A slower ramp-up of Kisunla dosing lowers the rate of dangerous brain swelling, a risk that has made doctors reluctant to ...

The biotech is taking inspiration from cystic fibrosis treatment and applying a similar approach to developing "corrector" and "potentiator" medicines for the kidney disease.

The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

The complaint argues Kennedy’s actions to remove the COVID vaccine from the CDC's immunization schedule for pregnant people ...

The cell therapy developer, which raised nearly $500 million in 2023 on the promise of its CAR-T work, has floundered since a ...

The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an ...

The success of Vertex's opioid alternative Journavx could aid a group of biotechs that aim to take a similar path with NaV1.8 ...

Coartem Baby, which was cleared by health authorities in Switzerland, will fill an important gap in treatment. Novartis plans ...

One analyst described Cogent’s data as a “home run scenario” for bezuclastinib, which the company is positioning as a ...